# K122450: Mhi-TM2000 Linear Accelerator System Vero Imavis

- Pathway: 510(k) (Traditional)
- Applicant: Mitsubishi Heavy Industries, Ltd.
- Decided: Oct 3, 2012 after 51 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K072047 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072047: Mhi-TM2000 Linear Accelerator System, Mitsubishi Heavy Industries, Ltd. (2007) Summary page 1.

## Most influential descendants
- K152867: MHI-TM2000 Linear Accelerator System, VERO, Imavis (2015), 0 descendants of its own

## Recalls of this device
- Dec 8, 2017 · Class II · Z-1585-2018: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
- Mar 7, 2016 · Class II · Z-1308-2016: In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first bea
- Dec 15, 2015 · Class II · Z-1244-2016: Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditi
- Apr 17, 2015 · Class II · Z-1574-2015: The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record
- Dec 2, 2014 · Class II · Z-0821-2015: Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. A
- Jul 5, 2014 · Class II · Z-2653-2014: Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treat
- Jun 21, 2013 · Class II · Z-1931-2013: Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record i

## Indications for use
MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K122450
Methodology: https://510kreport.com/methodology